BEUDAMED
    FDA Adverse Event Other Summary report: N

    ACRYSOF

    MDR report key: 1324831 · Received December 3, 2008

    Report

    Report Number
    1119421-2008-00971
    Event Type
    Other
    Date Received
    December 3, 2008
    Date of Event
    November 1, 2008
    Report Date
    November 3, 2008
    Manufacturer
    ALCON RESEARCH LTD. / HUNTINGTON
    Product Code
    HQL
    PMA / PMN Number
    P930014
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR ANALYSIS; THE DEVICE REMAINS IMPLANTED. RESULTS FROM THE PRODUCT HISTORY RECORD REVIEW INDICATED THE PRODUCT MET RELEASE CRITERIA. THERE HAVE BEEN NO OTHER COMPLAINTS REPORTED IN THE LOT NUMBER. ADDITIONAL INFORMATION WAS REQUESTED ON 11/04/2008, 11/10/2008 AND 11/17/2008 BY PHONE, FAX, AND MAIL. A COMPLETED QUESTIONNAIRE WAS RETURNED ON 11/10/2008.

    Description of Event or Problem · 1

    A CONSUMER REPORTED EXPERIENCING OCCASIONAL FLICKERING FOLLOWING BILATERAL INTRAOCULAR LENS (IOL) IMPLANT SURGERY. THE SURGEON REPORTED THAT HE DID NOT THINK THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT. IN A FOLLOW UP, THE SURGEON REPORTS THE OUTCOME OF THE EVENT AS "EXCELLENT". THERE ARE TWO MEDICAL DEVICE REPORTS ASSOCIATED WITH THIS EVENT. THIS REPORT IS FOR THE RIGHT EYE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACRYSOF INTRAOCULAR LENS HQL ALCON RESEARCH LTD. / HUNTINGTON SN60WF 10825528

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Other